Pathogen Safety

A number of steps are taken to minimize the risk of pathogen transmission

Careful donor screening and testing

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Only plasma from US donors is used; plasma frozen within 8 hours of collection1

  • Individual donor identification, registration and education
  • Deferral check, health screening, physical assessment, medical questionnaire and blood test at each donation
  • Absence of sexually transmitted diseases
  • Exclusion of donors not meeting acceptance criteria

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Nucleic Acid Testing (NAT) for:1

  • HIV
  • ParvoB19
  • HAV
  • HBV
  • HCV
  • HEV

Dedicated virus inactivation steps are implemented in manufacturing process

Virus
Optimized integration of plasma inactivates enveloped and non-enveloped viruses by immune neutralization1
No Virus
S/D treatment inactivates enveloped viruses, including Zika2, 3
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Octaplas is the ONLY FDA-licensed pooled S/D treated plasma for transfusion.

Virus reduction factors (log10) with Octaplas1

Enveloped Virus

Enveloped Viruses
HBV
(PRV model virus)
≥ 5.03
HIV-1
(HIV-1 model virus)
≥ 6.18
HCV
(SBV model virus)
≥ 5.31
WNV
(BVDV model virus)
≥ 5.12

Non-Enveloped Virus

Non-Enveloped Viruses
HAV
≥ 10.0
HEV
≥ 5.9
ParvoB19
≥ 7.0

HIV=Human Immunodeficiency Virus; HBV=Hepatitis B Virus; HCV=Hepatitis C Virus; WNV=West Nile Virus; HAV=Hepatitis A Virus; HEV=Hepatitis E Virus; ParvoB19=Parvovirus B19; PRV=Pseudorabies Virus; SBV=Sindbis Virus; BVDV=Bovine Viral Diarrhea Virus.

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The Octaplas production process is designed to maintain plasma proteins in their natural form.

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Octapharma’s manufacturing process meets FDA standards for safety in plasma collection and production1

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References:
  1. Octapharma. Data on file; 2013.
  2. Octaplas, Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion, complete prescribing information. 2019.
  3. Kühnel D, Müller S, et al. Inactivation of Zika virus by solvent/detergent treatment of human plasma and other plasma-derived products and pasteurization of human serum albumin. Transfusion. 2017 Mar;57(3pt2):802-810.